GCX Channel Mounting Accessory Screws May Loosen or Pull Out
Skytron recalls its GCX Channel Mounting Accessory (model H8-300-40-A) because mounting screws may loosen or pull out when used as a monitor mount on surgical booms. Affected units were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves mounting screws that may loosen or pull out from a surgical boom mount. No deaths, hospitalizations, or reported injuries are documented. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (score 3).
Plain-English summary
Skytron, Div. The KMW Group, Inc is recalling the GCX Channel Mounting Accessory, model H8-300-40-A, a mounting bracket used with surgical equipment booms to attach monitors.
Under certain circumstances, the mounting screws securing the accessory may loosen or pull out from the attachment point on the Ergon 3 boom when the accessory is used with the VST clamp as a monitor mount.
A total of 731 units are affected. The accessory was distributed worldwide to customers in the United States, Canada, and Japan.
Consumers who believe they have affected equipment should contact Skytron for information about the recall and any available remedy.
The recalled product
- Product
- Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
- Manufacturer
- Skytron, Div. The KMW Group, Inc
- Hazard
- Affected units
- 731
Distribution
Distributed nationwide across the United States.
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